Clinical trials: Validation Studies
Colorectal Cancer
Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"
The primary objective of this sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).
- Trial name
- NCT04144751
- Testing
- Blood Sample Collection
- Where
- 194 sites in United States
- Volunteers
- 23,494 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
COVID-19, Sars-CoV-2 Infection
This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.
- Trial name
- NCT05491993
- Testing
- Sky Medical™ Rapid Antigen Test
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Sky Medical Supplies & Equipments, LLC
Idiopathic Growth Hormone Deficiency, Turner Syndrome
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner…
- Trial name
- NCT01419249
- Testing
- Blood sampling
- Where
- 31 sites in Argentina, Canada and 7 more
- Volunteers
- 458 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Migraine Disorders
Treximet ™ Pharmacy Budget Impact Model Database Validation Study
The purpose of this retrospective claims database study was to compare the change in migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine suffers following initiation of Treximet ™…
- Trial name
- NCT01332500
- Testing
- Sumatriptan/Naproxen combination, other oral triptans
- Volunteers
- 61,737 people
- Sponsor
- GlaxoSmithKline
Gout
Validation Study of Physical Measurement of Tophi
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
- Trial name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
Alzheimer's Disease
A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease
The primary objective of this study is to develop and validate claims-based algorithms to identify intracerebral hemorrhage >1 cm in diameter, ensuring differentiation from amyloid-related imaging abnormality-microhemorrhage and…
- Trial name
- NCT07723950
- Testing
- No intervention
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Eisai Inc.
MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
AGED Diagnostics Clinical Validation Study
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the…
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Fibrosis and Cirrhosis of Liver, MetALD
- Trial name
- NCT07867574
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
Validation Studies
Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements.
- Trial name
- NCT02555462
- Testing
- Real-Ear Measurement system integrated in hearing aid fitting software
- Where
- Switzerland
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Phonak AG, Switzerland
Ventricular Dysfunction, Left, Ventricular Function, Left
Federated Learning for Point-of-Care Cardiac Ultrasound
This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations.
- Conditions
- Ventricular Dysfunction, Left, Ventricular Function, Left, Echocardiography, Ultrasonography
- Trial name
- FL-POCUS (NCT07800962)
- Testing
- Focused Cardiac Point-of-Care Ultrasonography, FL-POCUS Federated Machine-Learning Analysis System
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Truway Health, Inc.
Rheumatoid Arthritis
Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy
Study Design \& Objectives: Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.
- Trial name
- PRINT (NCT01299545)
- Where
- 37 sites in Canada, France and 6 more
- Volunteers
- 123 people
- Sponsor
- TcLand Expression S.A.
Osteoporosis, Osteopenia
Bone UltraSonic Scanner (BUSS): Validation Study
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
- Trial name
- NCT01439139
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
Refractive Errors
Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health…
- Trial name
- NCT05049070
- Testing
- Mobile medical application to self administer a subjective refraction test, Standard of care refraction test
- Where
- 12 sites in United States
- Volunteers
- 349 people
- Sponsor
- 1800 Contacts, Inc.
Influenza A, Influenza B
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02767414
- Testing
- Respirio Flu Test, eLab Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 7 sites in Australia
- Volunteers
- 1,500 people
- Sponsor
- Ellume Pty Ltd
Atopic Dermatitis, Psoriasis
Analytical Validation of Wrist-Based Assessment of Nocturnal Scratch in Atopic Dermatitis and Psoriasis
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the…
- Trial name
- DECODE-Scratch (NCT06448689)
- Where
- France
- Volunteers
- 90 people
- Sponsor
- ActiGraph L.L.C
Lung Cancer
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population.
- Trial name
- DELFI-L201 (NCT05306288)
- Testing
- Blood Sample Collection
- Where
- 67 sites in United States, Puerto Rico
- Volunteers
- 11,935 people
- Sponsor
- Delfi Diagnostics Inc.
Validation Study
Gait Metric Validation of the Cionic Neural Sleeve
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway.
- Trial name
- NCT06503354
- Testing
- Neural Sleeve and Zeno walkway
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cionic, Inc.
Chronic Obstructive Pulmonary Disease (COPD)
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment.
- Trial name
- WearME-Pro (NCT07430605)
- Testing
- WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator), Cardea SOLO ECG patch (optional subset; exploratory HR reference)
- Where
- 3 sites in United States
- Volunteers
- 82 people
- Sponsor
- LASARRUS Clinic and Research Center
Venous Thromboembolism
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)
The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)
- Trial name
- PREDICARE (NCT03099031)
- Testing
- Tinzaparin
- Where
- France
- Volunteers
- 420 people
- Sponsor
- LEO Pharma
Respiratory and Pulse Rate Accuracy Validation
Binah.ai Visual Vitals Application - Validation Study
The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a…
- Trial name
- NCT05539612
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Binah.ai LTD.
Non-Small Cell Lung Cancer
Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
The purpose of this study is to collect information about how a doctor uses the results of the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients.
- Trial name
- INSIGHT (NCT03289780)
- Where
- 42 sites in United States
- Volunteers
- 5,006 people
- Sponsor
- Biodesix, Inc.